Post Term Pregnancy - Induction of Labor or Monitoring of Pregnancy

Perinatal Morbidity Clinical Trial

Official title:

Post Term Pregnancy - Induction of Labor or Monitoring of Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00385229
• Other study ID #: REK 106-01
• Status: Completed
• Phase: N/A
• First received: October 6, 2006
• Last updated: November 3, 2011
• Start date: September 2002
• Est. completion date: July 2004

Study information

• Verified date: November 2011
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial Summary

Post term pregnancy is a risk pregnancy. Aim of the study was to investigate whether induction of labor at gestational age 289(41 weeks+2 days) reduces neonatal morbidity compared to expectant management. Secondary aims was to assess the effect on mode of delivery and maternal complications, as well as assess women's views and experiences.

Our 0-hypothesis was that induction of labor at gestational age 41+2 did not result in better outcome of pregnancy, measured as perinatal morbidity.

Following inclusion, women were randomly allocated to induction of labor or to monitoring of pregnancy every third day until delivery

Recruitment information / eligibility

• Status: Completed
• Enrollment: 508
• Est. completion date: July 2004
• Est. primary completion date: December 2003
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion criteria:

• Routine ultrasound scan and delivery at St.Olav's Hospital

• Ability to speak Norwegian

• Singleton pregnancy

• Gestational age 289 +/- 2 days

• Cephalic presentation

Exclusion criteria:

• prelabor rupture of membranes

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Perinatal Morbidity
• Pregnancy, Prolonged

Intervention

Drug:
• induction of labor
Misoprostol, Dinoprostone, amniotomy, Oxytocin

Locations

Country	Name	City	State
Norway	Department of Obstetrics, St.Olavs Hospital, Trondheim University Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Heimstad R, Skogvoll E, Mattsson LA, Johansen OJ, Eik-Nes SH, Salvesen KA. Induction of labor or serial antenatal fetal monitoring in postterm pregnancy: a randomized controlled trial. Obstet Gynecol. 2007 Mar;109(3):609-17. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neonatal morbidity		peri- en postnatal	No
Secondary	Maternal complications		peri- and postnatal	No
Secondary	Mode of delivery		at birth	No
Secondary	women's view		postpartum	No
Secondary	Women's experiences		perinatal	No
Secondary	Hormone levels		perinatal	No